FDA’s Double Standards Turn Deadly

The Food and Drug Administration routinely lets regulatory inefficiencies and outdated practices stand in the way of medical progress. Unfortunately, as recent events show, people often pay for this failure with their lives.

Drexel University sophomore and mechanical engineering major Stephanie Ross died last week after contracting type B meningitis while visiting friends from Princeton University. Type B is a deadly strain of meningitis, but the FDA has not approved the vaccine—even though it has been safely used in the United States and around the world.

The FDA gave Princeton University and University of California, Santa Barbara students special exemptions to use the vaccine after the universities’ recent type B meningitis outbreaks, but only after much delay. The FDA should know that vaccines are most valuable before outbreaks occur, not months after people have started falling ill. If Ms. Ross had been able to get the vaccine, she might well be alive today.

The Centers for Disease Control and Prevention’s website states, “After getting the first dose of the vaccine, it will take about 2 weeks for the body’s immune system to develop enough protection (antibodies) to help prevent serogroup B meningococcal disease [type B meningitis].” While meningitis outbreaks develop slowly, this delay, combined with the inevitable delay from the FDA, puts people at risk. Type B meningitis is a serious disease that kills 10 percent of people who contract it and permanently disables even more. About 150-200 cases are reported each year.

Most states require that college students receive vaccinations against other types of meningitis. It is surprising that government is forcing people to be vaccinated against certain strains of a disease, while on the other hand government is legally prohibiting individuals from vaccinating themselves against a particularly deadly form of the same disease.

The FDA does not see the recent tragedy as a sign of another outbreak. This means, for the time being, students at Drexel and individuals in the rest of the country are not free to vaccinate themselves. Princeton students are home for spring break, and their families and friends are left helpless and unnecessarily at risk of catching the disease. Apparently the right to self-defense stops where the FDA’s authority begins.

The FDA is responsible for creating an environment where a vaccine that has been proven safe and is approved for use in Canada, Australia, and the European Union cannot help Americans. Companies know the immense financial costs, time commitment, and regulatory uncertainty associated with getting the FDA’s approval for a drug. Because of this, they often hesitate at the barriers to bringing a drug to market—to the detriment of consumers.

Surprisingly, the FDA admits the vaccine against type B meningitis is safe. The vaccine is referred to as an “investigational new drug.” If the FDA agrees that the drug is safe, and has approved it for the entire Princeton and UCSB campuses, why is it still not available for widespread legal use in the United States? The answer boils down to an institutional problem that causes specific harm, and even death, to Americans.

If the FDA were subject to the same rigorous standards it applies to companies, it would fall far short of meeting them, according to a new Mercatus Center study by Jerry Ellig and James Broughel. They write, “Maybe it’s time that the safety and effectiveness standard applied to drugs should also be applied to regulations.”

Regulations have many unseen consequences. It is difficult, if not impossible, to quantify the number of people who would have been saved, or medical innovation that would have happened—if not for over-zealous FDA regulations. Projecting the effectiveness of government regulations is difficult and often imprecise, so government agencies rarely take into account the tradeoffs that regulations create.

The FDA is a particularly egregious example of this. It does not regularly substantiate its claims that there are problems which require intervention in the marketplace. Similarly, the FDA often fails to provide evidence that regulations the agency proposes are likely to produce actual benefits to the public or solve perceived problems.

Congress needs to require that the FDA take these factors into account when crafting regulations.

The FDA is over-cautious by design. Approving drugs or products that prove to be unsafe often leads to intense negative responses. Sometimes when the FDA fails to approve safe drugs or products, this only leads to unseen outcomes. But with Stephanie Ross, the outcome was visible—she died because she was denied access to the vaccine.

Manhattan Institute Senior Fellow Peter Huber argues in his new book, The Cure in the Code, that 20th century law is undermining 21st century medicine. FDA spending increased 65 percent in real terms between 2008 and 2012 and by more than 270 percent between 1990 and 2012. Even with greater funding the FDA has been unable to keep up with innovations in modern medicine. What it has done is add over 1,000 regulations between 2008 and 2012 that restrict individuals’ behavior. In effect, the FDA is doing its best to constrain medical progress rather than adapt itself to lifesaving medical innovation.

Ms. Ross’s case shows that an agency tasked with protecting the public has grown into a smothering bureaucracy. Modern medicine provides hope to save lives, and the FDA needs to help turn this hope into reality.

Jared Meyer is a policy analyst at Economics21 at the Manhattan Institute for Policy Research. You can follow him on Twitter here.

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